Aldeyra Therapeutics, Inc. (ALDX) Shareholder Notice: Robbins LLP Reminds Shareh… – Press Release

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SAN DIEGO, Aug. 04, 2023 (GLOBE NEWSWIRE) —

Robbins LLP reminds investors that a shareholder filed a class action on behalf of investors who purchased or otherwise acquired Aldeyra ALDX securities between March 17, 2022 and June 20, 2023. Aldeyra, a biotechnology company, develops and commercializes medicines for immune-mediated diseases. The Company is currently developing ADX-2191, a dihydrofolate reductase inhibitor for the treatment of primary vitreoretinal lymphoma cancer, proliferative vitreoretinopathy, and retinitis pigmentosa, as well as rare retinal diseases characterized by inflammation and vision loss.

For more information, submit a form, email Aaron Dumas, Jr., or give us a call at (800) 350-6003.

What is this Case About: Aldeyra Therapeutics, Inc. (ALDX) Misled Investors Regarding the Viability and Efficacy of its Drug Candidate

According to the complaint, during the class period, defendants made false and/or misleading statements and/or failed to disclose that: (i) the ADX-2191 NDA did not include adequate and well-controlled investigations and thus failed to show substantial evidence of ADX-2191’s effectiveness; (ii) as a result, the FDA was unlikely to approve the ADX-2191 NDA in its current form; and (iii) accordingly, the Company had overstated ADX-2191’s clinical and/or commercial prospects.

On June 21, 2023, Aldeyra announced “receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).” The Company stated that “[a]lthough no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a ‘lack of substantial evidence of effectiveness’ due to ‘a lack of adequate and well-controlled investigations’ in the literature-based NDA submission.” On this news, Aldeyra’s stock price fell $2.92 per share, or…

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